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POSITION SUMMARY
The Principle/Senior Regulatory Affairs Specialist under Regulatory Affairs Innovative Pathway team is to provide expert clinical support on NMPA registrations, especially for planning the clinical pathway for product, clinical evaluation report (CER) preparation, and clinical regulation/guidance input on the clinical trial design/documents to support NMPA registration, etc. This position also will be responsible for the innovative special pathways for accelerating the product registration or launch in China, like the Green Channel, Prioritize Review, Boao/GBA/National level special commercial use, etc.
KEY RESPONSIBILITIES
1. China Clinical Pathway for NMPA Registration
- Lead and responsible for planning the clinical pathway of product registration in China, ensure the implementation &updating of clinical strategy throughout the NMPA approval cycle.
- Serves as subject matter expert (SME) on China clinical regulations, provide expert clinical regulatory support to the RA team and Medtronic.
2. Clinical Evaluation Report and Global Clinical Evidence Leverage
- Collaborate with global clinical/medical and cross-functional teams, ensure the CERs (including overseas clinical trial data reports) are fully compliant with the up to date NMPA requirements, Medtronic SOP & WI, and agreed timeline.
- Review and approve the CER documents on behalf of China RA, communicate with NMPA on the CER deficiency requirements.
- Prepare clinical evaluation materials including CER or overseas clinical data report per the clinical pathway to support timely NMPA registration.
3. Clinical Trial Regulatory Compliance
- As China RA representative, review and approve the overseas/in-China clinical trial design & materials for NMPA registration, and the External Research Programs (ERPs) in China.
4. Innovative Pathway
- Responsible for fully leveraging the innovative pathways (e.g. Green Channel, Prioritize review, etc.) to accelerate the NMPA registration, assess the feasibility and risk of the innovative pathway from clinical value perspective, and responsible for preparing the innovative pathway application dossiers from clinical part.
- Responsible for applying the special commercial use in Boao, GBA or follow the NMPA policy.
JOB QUALIFICATIONS
- Thorough knowledge of NMPA medical device regulations, especially clinically relevant regulations/guidance.
- Demonstrated ability to identify and solve problems independently.
- Ability to work with a cross-functional team;
- Effective verbal and written communication skills and presentation skills in both English and Mandarin;
Proven record of successful completion of complex tasks.
DESIRABLE
- Master’s degree in medicine, biostatistics, healthcare, public health, statistic or related area is preferred;
- 3 years or above experience in China clinical pathway planning, China clinical evaluation, and experience in scientific writing is highly preferred;
In addition to above, experience in clinical trial design and execution, or education background of statistics is nice to have.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
